Patient Activated Controlled Expansion (PACE) Trial (PACE)
|Breast Cancer Mastectomy Breast Reconstruction||Device: Patient Activated Controlled Expansion Device|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation|
- Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure. [ Time Frame: 6 months ]
- Safety as evidenced by a low incidence of device-related adverse events. [ Time Frame: 6 months ]
- Time required to achieve desired expansion results. [ Time Frame: 6 months ]
- Overall patient treatment satisfaction. [ Time Frame: 6 months ]
- Overall surgeon treatment satisfaction. [ Time Frame: 6 months ]
|Study Start Date:||June 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Post-mastectomy patients undergoing expander reconstruction
Device: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction
Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.
Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.
Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.
Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.
Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.
Each patient will be followed through removal of the tissue expander.
The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009008
|Australia, Western Australia|
|The Mount Hospital|
|Perth, Western Australia, Australia, 6000|
|Principal Investigator:||Anthony Connell, M.D.|